Actively Recruiting
Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
Led by Renovion, Inc. · Updated on 2025-12-09
100
Participants Needed
20
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this Phase 3 clinical trial is to compare ARINA-1 (a nebulized immunomodulatory agent) plus Standard of Care vs Standard of Care alone. The main question it aims to answer are: * Evaluate the effectiveness of ARINA-1 in preventing bronchiolitis obliterans syndrome (BOS) progression in participants with a bilateral lung transplant * To evaluate the effectiveness of ARINA-1 on improving quality of life decline and preventing or delaying the use of augmented immunosuppression in participants with pre-BOS relative to SOC. Participants will have clinic visits at screening, randomization (day 1) and weeks 4, 12, 18, and 24. After week 24, participants will have clinic visits at weeks 32, 40, and 48. Participants will also have a telehealth visit on day 2 and phone calls to assess adverse events (AEs), serious adverse events (SAEs), and review patient education will occur during weeks 5, 8, 36, and 44.
CONDITIONS
Official Title
Study to Evaluate ARINA-1 in the Prevention of Bronchiolitis Obliterans Progression in Participants With Bilateral Lung Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bilateral lung transplant more than 12 months before randomization
- Age between 18 and 75 years at consent
- Routine follow-up at enrolling site
- Willing and able to comply with visit schedule and home requirements
- 10-24% decrease in FEV1 from post-transplant baseline within last 12 months
- Able to provide informed consent
- Stable azithromycin use for more than 4 weeks before screening
- Stable 2- or 3-agent immunosuppression regimen including steroid and calcineurin inhibitor for over 4 weeks before screening
- Women of childbearing potential must agree to reliable birth control during the study
You will not qualify if you...
- Positive urine pregnancy test at screening and baseline
- Active congestive heart failure or symptomatic coronary artery disease above grade 3 (NYHA criteria)
- Restrictive allograft syndrome shown by chest X-ray or CT scan
- Advanced bronchiolitis obliterans syndrome with more than 24% decrease in FEV1
- Probable antibody-mediated rejection diagnosed within 12 months before baseline
- Donor-specific antibodies identified less than 6 months before baseline
- Unresolved diffuse alveolar damage
- Currently receiving mechanical ventilation
- Chronic kidney disease stage IV or higher, including dialysis
- Starting or changing maintenance immunosuppression therapy within 30 days before baseline
- Starting or changing mTOR therapy less than 3 months before screening
- Starting or changing antibiotic, antiviral, or antifungal therapy less than 14 days before baseline
- Use of alemtuzumab less than 6 months before baseline
- Use of anti-thymocyte therapies or photopheresis less than 90 days before screening
- Starting multivitamins or supplements containing vitamin C, glutathione, or N-acetylcysteine less than 90 days before baseline
- Unstable significant comorbidities
- Allergy or previous adverse reaction to azithromycin
- Diagnosis of dynamic collapse or tracheobronchomalacia less than 90 days before baseline
- Participation in other interventional clinical studies less than 30 days before baseline
- Diagnosis of ARAD within 6 weeks before screening
- Use of belatacept less than 6 months before screening
- Bronchial stents or cryotherapy treatment within 12 months before screening, or stent removal within last 3 months before screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
Dignity Health - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Withdrawn
2
University of California Los Angeles School of Medicine
Los Angeles, California, United States, 90095
Actively Recruiting
3
University of California San Diego Health
San Diego, California, United States, 92103
Actively Recruiting
4
Advent Health
Orlando, Florida, United States, 32803
Actively Recruiting
5
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
6
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Actively Recruiting
7
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
9
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
Withdrawn
10
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
11
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
12
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43221
Actively Recruiting
14
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19122
Not Yet Recruiting
15
Medical University of South Carolina
Charleston, South Carolina, United States, 29452
Actively Recruiting
16
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 45390
Actively Recruiting
17
Baylor Scott and White Research Institute
Dallas, Texas, United States, 75246
Actively Recruiting
18
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
19
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
20
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
C
Carolyn Durham, PhD
CONTACT
W
Will Anderson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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